(80 days)
Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices. The description focuses on the mechanical function of a surgical stapler.
No.
This device is a surgical stapler used for creating anastomoses, which is a surgical tool rather than a therapeutic device in the sense of treating a disease or condition.
No
Explanation: The device is a surgical stapling device used for creating anastomoses, which is a therapeutic function, not a diagnostic one.
No
The device description explicitly states it is a "surgical stapling device," which is a hardware component. The term "Digital Loading Units" might imply some digital control or interface, but the core function is mechanical stapling.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical stapling device used for creating anastomoses (connections) within the alimentary tract. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is described as a surgical stapling device used for creating a circular anastomosis. This confirms its role in a surgical procedure.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue) outside the body to provide information about a patient's health. The description of this device does not involve the analysis of any biological specimens.
Therefore, the Power Circular Stapler Digital Loading Units® is a surgical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Power Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
Product codes
GDW
Device Description
Power Circular Stapler Digital Loading Units® are single use, disposable, surgical stapling devices designed for creating a circular anastomosis between two tubular structures and/or tissue layers. The rigid length of the Power Circular Stapler Digital Loading Units® have been reduced by relocating portions of the gearing into the proximal end of the device, while redesigning the anvil clamping mechanism. There are Power Circular Staplers which incorporate a retractable dilator that is attached to the distal end of the DLU. The dilator provides a tapered leading edge, which eases DLU insertion.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
alimentary tract
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4750 Implantable staple.
(a)
Identification. An implantable staple is a staple-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.
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K061649
page i of 2
SECTION E - Special 510(k) Summary
1 2006
In Accordance with 21 CFR Section 807.92 Power Medical Interventions® is submitting the following safety and effectiveness summary.
- Submitter Information:
Power Medical Interventions, Inc. 2021 Cabot Blvd. Langhorne, PA 19047 267-775-8151 Ph 267-775-8123 Fax
Applicant:
Barbara J. Whitman
June 8, 2006 Date of Notification:
-
- Name of Device:
| Trade Name: | Power Circular Stapler Digital Loading Unit® |
|---|---|
| Common Name: | Circular Staplers with Implantable Staples |
| Classification Name: | Staple, Implantable, GDW |
-
- Predicate Devices:
SurgASSIST® Circular Stapler Digital Loading Units®, Power Medical Interventions, Inc., K003277.
- Predicate Devices:
4) Device Description
Power Circular Stapler Digital Loading Units® are single use, disposable, surgical stapling devices designed for creating a circular anastomosis between two tubular structures and/or tissue layers.
5) Device Modification
The Power Circular Stapler Digital Loading Units® cut and staple identically to the predicate device, Circular Stapler Digital Loading Units® (K003277). The rigid length of the Power Circular Stapler Digital Loading Units® have been reduced by relocating portions of the gearing into the proximal end of the device, while redesigning the anvil clamping mechanism. There are Power
Image /page/0/Picture/18 description: The image shows a sequence of numbers, specifically "000013". The numbers are printed in a bold, sans-serif font, and they appear to be part of a label or identification code. The numbers are uniformly sized and spaced, with a period at the end.
1
K061649
Page 2 of 2
Power Medical Interventions, Inc. Power Circular Stapler Digital Loading Units® Special 510(k) Device Modification PreMarket Notification - June 8, 2006
Circular Staplers which incorporate a retractable dilator that is attached to the distal end of the DLU. The dilator provides a tapered leading edge, which eases DLU insertion.
-
- Indications For Use
The Power Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
- Indications For Use
-
- Comparison to Predicate Devices
The Power Circular Stapler Digital Loading Units® have the same indications for use and the same functionality as the previously cleared predicate Circular Stapler Digital Loading Units® (K003277). Both the Power Circular Stapler Digital Loading Units® and the Circular Stapler Digital Loading Units® deliver two staggered rows of titanium staples on each side of a circular transection. For further details, please see the Predicate Comparison Chart in Section J of this submission.
- Comparison to Predicate Devices
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 1 2006
Power Medical Interventions % Ms. Barbara J. Whitman Regulatory Affairs Manager 2021 Cabot Boulevard West Langhorne, Pennsylvania 19047
Re: K061649
Trade/Device Name: Power Circular Stapler Digital Loading Units® Regulation Number: 21 CFR 878.4750 Regulation Name: Implantable staple Regulatory Class: II Product Code: GDW Dated: August 7, 2006 Received: August 8, 2006
Dear Ms. Whitman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This
3
Page 2 - Ms. Barbara J. Whitman
letter will allow you to begin marketing your device as described in your Section 510(k) nremarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Fuc Pdo Vr
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Power Medical Interventions, Inc. Power Circular Stapler Digital Loading Units® Special 510(k) Device Modification PreMarket Notification - K061649 Request for Additional Information - July 12, 2006
Indications for Use
510(k) Number (if known): K061649
Device Name: Power Circular Stapler Digital Loading Units®
Indications for Use:
The Power Circular Stapler Digital Loading Units® have applications throughout the alimentary tract for end-to-end, end-to-side, and side-to-side anastomoses.
Note: The Indications For Use for the Power Circular Stapler Digital Loading Units® are identical to that of the predicate device, Circular Stapler Digital Loading Units®, which were cleared to market via K003277.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sign Off
Page of _
(Division Sign-O Division of General, Restorative, and Neurological Devices
510(k) Number K061645